FASTLANE II: Reducing Sex, Drug, and Mental Health Risk

NCT04109014 | Completed

• 1 other identifier: UP-15-00628
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study uses a repeated measures, single group pretest-posttest design methodology to examine the feasibility, acceptability, and preliminary effectiveness of the FASTLANE II intervention aimed at decreasing risky sex behaviors among active methamphetamine using women. The study's methodology consists of two phases: 1) The feasibility and evaluation of recruitment capability and intervention effectiveness, and 2) qualitative acceptability interviews.

Conditions

Methamphetamine Abuse; HIV/AIDS; Depression; Sex, Unsafe

Keywords

Cognitive Behavioral; Qualitative Interviews; Motivational Interviewing

Outcome Measures

Primary Outcomes (4)

• Depression

  Participants will be asked to complete the Beck Depression Inventory (BDI-II) scale. A total of 21 items assess depressive symptoms over the past 2 weeks (including today), and are summed to create a summary score (alpha = 0.91). We used established cutoffs for minimal (0-13), mild (14-19), moderate (20-28), and severe depressive symptoms (29-63).

  9-12 weeks

• Sex Practices

  Assesses number of times participants engaged in sexual behavior, (vaginal, oral, and anal sex). Follow-up questions assess number of times these sexual acts were protected. Use of condoms or oral dams or nonpenetrative (e.g., manual sex) excluding oral sex. Using these data, three outcome variables will be used: (a) total protected sex acts, (b) total unprotected sex acts, and (c) percentage of safer sex behaviors (i.e., ratio) by dividing protected sex behaviors by the total number of sex behaviors over the past 2 months.

  9-12 weeks

• Negotiating Self-Efficacy for Safer Sex

  Seven questions pertaining to self-efficacy for negotiation of safer sex, including perceived ability to bring up the topic of safer sex with any partner, negotiate condom use with any partner, and convince a partner to use a condom if he or she resisted. Participants presented with a statement about being able to negotiate safer sex (e.g., ''I can persuade partners to try different types of condoms'') and rate agreement ranging from 1 (strongly disagree) to 4 (strongly agree). Total sum score with higher scores greater self-efficacy.

  9-12 weeks

• Methamphetamine Use

  Asked to report number of days and grams (or preferred unit) of methamphetamine used in the past 30 days. They will be asked how often they snort, smoked, injected, injected in combination with another drug, or used in any other way in the past 2 months. Response options 0 = never, 1 = once in a while, 2 = fairly often, and 3 = very often. The items will be summed to create a summary score of "frequency of meth use across different methods in the past 2 months." Amount responses will be converted to grams using a standard formula (e.g., 8 ball ¼ 3.5 g; ounce ¼ 28 g). Converted values will be multiplied by number of times used to calculate the number of grams of methamphetamine used in the past 30 days.

  9-12 weeks

Study Arms (1)

FASTLANE II Group

OTHER

Participants will participate in the FASTLANE II Intervention. Counseling sessions will focus on: 1) depressive symptoms, 2) methamphetamine use, and 3) sexual risk behaviors. Three sessions will be devoted to each topic area. Trained staff will use a client-centered approach and develop a goal for each area alongside the participant. Counseling sessions will remain confidential and will not be audio recorded.

Other: FASTLANE II

Interventions

FASTLANE II OTHER

The intervention will consist of nine weekly hour-long individual counseling sessions. The FL II sessions utilize a combination of Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) to reduce sexual risk behaviors and mental health symptoms. Thus, individuals develop a "toolbox" for mood self-management to improve emotional self-regulation and reduce maladaptive coping mechanisms to minimize drug and sex risk behavior. Participants will be considered as completing the FASTLANE Intervention upon completion of the nine weeks of sessions.

FASTLANE II Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of San Antonio, Texas
• Female
• Mexican-American
• HIV-negative
• years of age or older
• Self-identify as heterosexual
• Have had unprotected sex with at least one opposite sex partner during the previous 2 months
• Indicate that they have snorted or smoked methamphetamine at least once during the previous 2 months

You may not qualify if:

• Not a resident of San Antonio, Texas
• Male
• Not Mexican-American
• HIV-positive
• Younger than 18 years of age
• Do not self-identify as heterosexual
• Have not had unprotected sex with at least one opposite sex partner during the previous 2 months
• Indicate that they have not snorted or smoked methamphetamine at least once during the previous 2 months

Sponsors & Collaborators

• University of Southern California: lead
• University of California, San Diego: collaborator

Study Sites (1)

Proyecto SALTO Office

San Antonio, Texas, 78207, United States

Location

Related Publications (27)

• Rigby SW, Johnson LF. The relationship between intimate partner violence and HIV: A model-based evaluation. Infect Dis Model. 2017 Feb 16;2(1):71-89. doi: 10.1016/j.idm.2017.02.002. eCollection 2017 Feb.

  PMID: 29928730 BACKGROUND

• Ulibarri MD, Strathdee SA, Patterson TL. Sexual and drug use behaviors associated with HIV and other sexually transmitted infections among female sex workers in the Mexico-US border region. Curr Opin Psychiatry. 2010 May;23(3):215-20. doi: 10.1097/YCO.0b013e32833864d5.

  PMID: 20308903 BACKGROUND

• Zlotnick C, Johnson DM, Kohn R. Intimate partner violence and long-term psychosocial functioning in a national sample of American women. J Interpers Violence. 2006 Feb;21(2):262-75. doi: 10.1177/0886260505282564.

  PMID: 16368765 BACKGROUND

• Bonomi AE, Anderson ML, Cannon EA, Slesnick N, Rodriguez MA. Intimate partner violence in Latina and non-Latina women. Am J Prev Med. 2009 Jan;36(1):43-48. doi: 10.1016/j.amepre.2008.09.027.

  PMID: 19095164 BACKGROUND

• Ulibarri MD, Hiller SP, Lozada R, Rangel MG, Stockman JK, Silverman JG, Ojeda VD. Prevalence and characteristics of abuse experiences and depression symptoms among injection drug-using female sex workers in Mexico. J Environ Public Health. 2013;2013:631479. doi: 10.1155/2013/631479. Epub 2013 May 12.

  PMID: 23737808 BACKGROUND

• Mausbach BT, Semple SJ, Strathdee SA, Zians J, Patterson TL. Efficacy of a behavioral intervention for increasing safer sex behaviors in HIV-positive MSM methamphetamine users: results from the EDGE study. Drug Alcohol Depend. 2007 Mar 16;87(2-3):249-57. doi: 10.1016/j.drugalcdep.2006.08.026. Epub 2006 Dec 19.

  PMID: 17182196 BACKGROUND

• Zule WA, Costenbader EC, Meyer WJ Jr, Wechsberg WM. Methamphetamine use and risky sexual behaviors during heterosexual encounters. Sex Transm Dis. 2007 Sep;34(9):689-94. doi: 10.1097/01.olq.0000260949.35304.22.

  PMID: 17471112 BACKGROUND

• McCoy HV, McCoy CB, Lai S. Effectiveness of HIV interventions among women drug users. Women Health. 1998;27(1-2):49-66. doi: 10.1300/J013v27n01_04.

  PMID: 9640634 BACKGROUND

• Ennis, S., M. Rios-Vargas, & N.G. Albert, The Hispanic Population 2010. 2011.

  BACKGROUND

• Motel, S.E.P., Hispanics of Mexican Origin in the United States, 2010. 2012, Pew Research Center.

  BACKGROUND

• Telles, E.E.V.O., Generations of Exclusion: Mexican Americans, Assimilation, and Race. 2008, Russell Sage Foundation.

  BACKGROUND

• Caetano R, Field CA, Ramisetty-Mikler S, McGrath C. The 5-year course of intimate partner violence among White, Black, and Hispanic couples in the United States. J Interpers Violence. 2005 Sep;20(9):1039-57. doi: 10.1177/0886260505277783.

  PMID: 16051726 BACKGROUND

• Smith CA, Ireland TO, Park A, Elwyn L, Thornberry TP. Intergenerational continuities and discontinuities in intimate partner violence: a two-generational prospective study. J Interpers Violence. 2011 Dec;26(18):3720-52. doi: 10.1177/0886260511403751. Epub 2011 Aug 1.

  PMID: 21810795 BACKGROUND

• Jennings WG, Reingle JM, Staras SA, Maldonado-Molina MM. Substance Use as a Risk Factor for Intimate Partner Violence Overlap: Generational Differences Among Hispanic Young Adults. Int Crim Justice Rev. 2012 Jun 1;22(2):139-152. doi: 10.1177/1057567712442943.

  PMID: 25125930 BACKGROUND

• Nowotny KM, Frankeberger J, Rodriguez VE, Valdez A, Cepeda A. Behavioral, Psychological, Gender, and Health Service Correlates to Herpes Simplex Virus Type 2 Infection among Young Adult Mexican-American Women Living in a Disadvantaged Community. Behav Med. 2019 Jan-Mar;45(1):52-61. doi: 10.1080/08964289.2018.1447906. Epub 2018 May 9.

  PMID: 29558260 BACKGROUND

• United States Census Bureau, DP-1-Profile of General Population and Housing Characteristics: 2010. 2010.

  BACKGROUND

• Economic Innovation Group, The 2016 Distressed Communities Index: An Analysis of Community Well- Being Across the United States. Economic Innovation Group.

  BACKGROUND

• Quinn SC. Ethics in public health research: protecting human subjects: the role of community advisory boards. Am J Public Health. 2004 Jun;94(6):918-22. doi: 10.2105/ajph.94.6.918.

  PMID: 15249289 BACKGROUND

• Pitpitan, E.V., et al., Cognitive behavioral therapy for HIV-negative heterosexual meth users: the FASTLANE II intervention. Cognitive and Behavioral Practice, 2014. 21(2): p. 176-190.

  BACKGROUND

• Pitpitan EV, Semple SJ, Zians J, Strathdee SA, Patterson TL. Mood, Meth, Condom Use, and Gender: Latent Growth Curve Modeling Results from a Randomized Trial. AIDS Behav. 2018 Sep;22(9):2815-2829. doi: 10.1007/s10461-018-2147-9.

  PMID: 29754267 BACKGROUND

• Beck, A., R. Steer, and G. Brown, Manual for the BDI-II. 1996, San Antonio, TX: Psychological Corporation.

  BACKGROUND

• Corbin, J.M. and A. Strauss, Grounded theory research: Procedures, canons, and evaluative criteria. Qualitative sociology, 1990. 13(1): p. 3-21.

  BACKGROUND

• Glaser, B. and A. Strauss, Discovery of grounded theory: Strategies for qualitative review. 1967, Chicago, IL: Aldine De Gruyter.

  BACKGROUND

• LeCompte, M.D. and J.J. Schensul, Analyzing & interpreting ethnographic data. 1999: Rowman Altamira.

  BACKGROUND

• Ragin, C.C., The Comparative Method: Moving Beyond Qualitative and Quantitative Strategies. 1987, Los Angeles: University of California Press.

  BACKGROUND

• Ragin CC. Using qualitative comparative analysis to study causal complexity. Health Serv Res. 1999 Dec;34(5 Pt 2):1225-39. No abstract available.

  PMID: 10591281 BACKGROUND

• Spradley, J., The Ethnographic Interview. New York, NY: Holt, Rinehart and Winston. Inc, 1979.

  BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Unsafe Sex

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Sexual Behavior

Study Officials

• Alice Cepeda, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Quasiexperimental, single group pretest-posttest study design and qualitative interviews to evaluate feasibility, acceptability and effect.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: May 3, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)